This application claims priority to, and incorporates by reference, Chinese Patent Application No. 00205827.8 filed on Feb. 24, 2000.
1. Field of the Invention
The present invention relates to a syringe, particularly, to a safety syringe, belonging to the medical device technical field. Safety syringes are designed for one-time use and are, therefore, not re-useable.
2. Background of the Art
In the medical field, there is a great need to avoid cross-contamination or infection which may be caused when a syringe is used more than once. Single use syringes have long been thought as being one way to avoid these potential problems. However, current single use syringes present a variety of problems. Some syringes which claim to be xe2x80x9csingle usexe2x80x9d in actuality can be reused with user intervention. Some syringes are designated as xe2x80x9csingle usexe2x80x9d solely because they are to be discarded after use pursuant to a regulation; nothing prevents their reuse. Some syringe designs expose the drug or bodily fluid contained therein to reactive components of the syringe (e.g. a spring used to retract the plunger). In addition, some syringes, although not capable of being reused, present health risks to the medical personnel handling them. Accordingly, there is a need for a single use syringe which is: (a) easy to use; (b) incapable of being reused; (c) presents little or no danger to medical personnel after use; (d) designed in such a way as to prevent contact between reactive syringe components and the fluid contained within the syringe; and (e) capable of being manufactured at low cost.
Currently, there are mainly two classes of safety syringes. One class of syringes, which employs a spring to retract a needle into the syringe, is represented in U.S. Pat. Nos. 5,769,822, 5,980,494, and 6,039,713. Although these syringes are effective and easy to use, the also have inherent disadvantages. First, the spring-loaded structure is complicated because of the number of parts involved creates difficulties in constructing the syringe. Second, due to the complicated structure, the costs of manufacturing are high making marketing difficult. Third, due to the location of the spring at the needle end of the syringe, it is difficult to position the fluid close to the inlet to the needle; this increases fluid residue and makes removal of air bubbles more difficult.
The second class of syringes employs a locking mechanism on the plunger which engages a corresponding structure at the base of the needle when the plunger is completely compressed. A subsequent withdrawal of the plunger pulls the needle into the syringe barrel. The structure of these syringes is simpler and the cost of production lower in comparison to the former class. However, this class of syringes also has disadvantages. For example, in Chinese Patent CN2270509Y, the corresponding parts of the locking mechanism between the needle and the plunger are exposed to fluid contained within the syringe. Accordingly, any burrs on the parts which result from manufacturing may fall into the fluid and be thereafter accidentally transmitted to the patient giving rise to a potentially dangerous situation. In addition, in many of these syringes, the locking mechanism can be disengaged and the syringe reused.
U.S. Pat. No. 5,601,534 discloses a one-time-use safety syringe comprising a simple structure which reliably releases gases and retains a very small amount of residual fluid. However, it also presents disadvantages. The structure employs an inward facing needle extension which is bent by an arrowhead attached to the plunger. The extension is bent into a cavity in the plunger such that when the plunger is pulled away from the needle, the needle is pulled into the syringe barrel.
A first disadvantage is that the size of the extension must correspond to the size of the needle; a large needle requires a large extension which is not as easily bent thereby degrading the integrity of the engagement with the plunger.
A second disadvantage is that the rubber stopper, which houses the cavity, is solid. Due to the solid nature of the stopper, the extension must completely pierce the stopper to create a strong engagement with the cavity. To create this strong engagement requires a strong compression of the plunger at the completion of the injection; this can be difficult when the needle and needle extension are large.
A third disadvantage results with large needles. A large compressive force needs to be applied to the plunger to complete an injection with a large needle. This force counteracts the force necessary for the needle extension to puncture the plunger. To address this problem, the needle""s engagement with the barrel head needs to enhanced. However, by enhancing the needle""s engagement with the barrel head, it becomes more difficult to withdraw the needle into the syringe barrel after the injection is complete.
Fourth, the engagement of the needle extension and the plunger is such that upon withdrawal of the needle into the syringe barrel, residual fluid in the barrel can leak out of the syringe.
Fifth, the size of the plunger cavity corresponds to the size of the needle. Accordingly, one plunger can not be used with a variety of needle sizes. Therefore, medical personnel must maintain an inventory of various sizes of plungers which is costly and which occupies precious storage space.
A solution to the aforementioned deficiencies in the art are resolved by the safety syringe herein described. Specifically, the presently described syringe has the following advantages over the prior art: (a) the hooks within the stopper which engage the arrowhead are not in contact with the fluid contained in the syringe thereby reducing the potential for manufacturing burrs to fall into the fluid and thereby be injected into the patient. The structure is possible because the engagement of the needle holder and the plunger occurs when the arrowhead pierces the stopper membrane. After the completion of the injection thereby establishing this engagement, the syringe can not be reused. Moreover, the puncturing of the membrane requires a force which is much smaller than the force necessary to compromise the o-ring seal in the plunger neck; accordingly the counteractive force problems in the prior art are eliminated; (b) the o-ring positioned in the syringe neck prevents fluid from escaping when the needle is initially pulled toward the syringe barrel; (c) the syringe has a simple structure which is both easy to use and manufacture; (d) the cavity in the stopper and the arrowhead can be used with any size needle (i.e. the size of the cavity and the arrowhead is not dependent on the size of the needle); and (e) the size of the needle does not compromise the integrity of the locking between the plunger and the needle holder.
These and other advantages are made possible by a safety syringe comprising a syringe casing having a distal end and a proximal end. A plunger is channeled in the syringe casing and is capable of moving from an extended position to a compressed position. The plunger has a weak portion, a distal portion, and a coupling portion. A stopper, having a membrane, is affixed to the coupling portion of the plunger; the membrane is between the proximal end of the syringe casing and the plunger. A needle holder, initially coupled to the proximal end of the syringe casing, has a distally facing arrowhead and a proximally facing needle. When the plunger is moved from the extended position to the compressed position, the arrowhead punctures the membrane and lockingly engages the coupling portion of the plunger. Subsequently, when the plunger is returned to the extended position, the needle holder and needle are drawn into an interior of the syringe casing.
In the safety syringe above-described, the weak part of the plunger may include a plurality of tines. In this situation, when the plunger is returned to the extended position from the compressed position, the distal portion of the plunger may be disengaged from the weak portion by breaking the tines.
In a preferred embodiment, the safety syringe includes a plurality of o-rings formed on an outer surface of the stopper. The plurality of o-rings frictionally engage an inner surface of the syringe casing when the plunger is moved between the extended position and the compressed position.
In the safety-syringe above-described, the proximal end of the syringe casing comprises a cylindrical neck portion which houses the needle holder. The cylindrical neck portion comprises a circumferential channel formed on an inner surface thereof. The needle holder comprises a circumferential o-ring on an outer surface thereof which is sized to substantially fill the channel.
The safety-syringe may also include a safety mechanism. The safety mechanism comprises a check plate which is affixed to an outer surface of the syringe casing and which is adapted to move from an unlocked position to a locked position. The check plate is designed to engage a notch in a side of the distal portion of the plunger. When the check plate is in the locked position, it engages the notch thereby preventing the plunger from moving from the extended position to the compressed position.
In the presently described safety syringe, the needle and the syringe casing have longitudinal axes. Before engagement of the arrowhead and the coupling portion, the needle axis and the syringe casing axis are substantially parallel. By way of contrast, after the needle holder and the needle are drawn into the interior of the syringe casing, a mechanism alters the orientation of the needle axis with respect to the syringe axis so that they are not substantially parallel. Additionally, the proximal end of the syringe casing comprises a cylindrical neck portion which houses the needle holder; a circumferential wall extends from an interior end of the cylindrical neck portion to an outer surface of the proximal end of syringe casing. Due to the misalignment of the needle axis and the syringe casing axis, the needle will contact the wall if the plunger is moved toward the compressed position.
Ideally, the stopper substantially covers the coupling portion of the plunger when the plunger is in the extended position. Moreover, when the plunger is in the compressed position (i.e., after engagement of the arrowhead and the coupling portion housed within the stopper), the stopper substantially covers the arrowhead and the coupling portion.
A second embodiment of a safety syringe includes a syringe barrel and a needle holder, having an arrowhead at a rear portion thereof, sealingly installed onto a front end of the syringe barrel. The arrowhead has a circumferential groove disposed at its base. A needle is sleeved onto the needle holder. A cylindrical rubber stopper, coupled to a plunger, has a membrane at on one end and a bore at the other end. The plunger has an coupling portion dimensioned to engage the arrowhead. The rubber stopper is hollow and is sleeved over the plunger coupling portion. Moreover, the plunger is moveable between an extended position and an compressed position at which an injection is completed. The rubber stopper and the plunger are sequentially installed into the syringe barrel.
In the syringe of this type, the membrane end of the rubber stopper faces the arrowhead; at the completion of the injection, the arrowhead pierces the membrane and engages the coupling portion. After this engagement, when the plunger is drawn backwards towards the extended position, the needle holder and the needle are drawn into the syringe barrel.
Preferably, the syringe also includes an inner sealing channel on an internal side of the front end of the syringe barrel. Correspondingly, a sealing ring sleeved onto the needle holder is preferably dimensioned to match the inner sealing channel. A rear portion of the inner sealing channel should have a smaller arc than an arc of the sealing ring. Moreover, a frontal portion of the inner sealing channel should have an inclined face having an arc larger than the arc of the rear portion. In a syringe having these channel characteristics, the needle holder can be slideably engaged in the front end of the syringe barrel by means of the sealing ring and can be moved in the direction of the syringe barrel when the plunger is withdrawn are engagement of the arrowhead and coupling portion.
The plunger in a safety syringe of this nature preferably comprises a weak portion and a resistance plate fixedly connected to the coupling portion. Moreover, the plunger preferably has a xe2x80x9c+xe2x80x9d shaped formed by a vertical rib plate and a horizontal cross rib plate. The vertical rib plate is weakly connected to the resistance plate by means of a plurality of tines. After completion of the injection and after the needle holder and needle are drawn into the syringe barrel, the tines of the weak portion can be broken upon application of a bending moment.
Similar to the first embodiment, the safety syringe may also include a mechanism by which premature use of the syringe is prevented. Specifically, the syringe may include a safety mechanism having a wing plate, a check plate, and a flexible film connecting the wing plate and the check plate. The safety mechanism is positioned on an exterior surface of the syringe barrel at a position proximate to an insertion bore into which the plunger is inserted. The check plate and one rib of the vertical rib plate have corresponding grooves which may be engaged if the check plate is rotated toward the vertical rib plate by means of the flexible film. If the grooves of the check plate and the vertical rib plate are engaged, premature completion of the injection is prevented.
Ideally, a plane forming the base of the arrowhead is not perpendicular to a central axis of the syringe barrel. In this fashion, after the needle is drawn into the syringe barrel, the axis of the needle will be directed toward an inner wall of the syringe barrel; a subsequent re-compression of the plunger toward the compressed position will cause the needle to abut the inner wall of the syringe barrel.
The present invention also contemplates a method for preventing reuse of a syringe. The method uses a syringe having a syringe casing which, in turn, has a longitudinal axis, a distal end, and a proximal end having a cylindrical neck portion. In the syringe used by the method, a circumferential wall extends from an interior end of the cylindrical neck portion to an outer surface of the proximal end of syringe casing. A plunger having a weak portion, a distal portion, and a coupling portion, is channeled in the syringe casing and is moveable from an extended position to a compressed position. A stopper having a membrane is affixed to the coupling portion of the plunger; the membrane is between the proximal end of the syringe casing and the plunger. A needle holder, housed in the cylindrical neck portion of the syringe casing, has a distally facing arrowhead and a proximally facing needle having an axis and a needle tip.
The method includes: (I) moving the plunger from the extended position to the compressed position; (II) puncturing the membrane with the arrowhead when the plunger is in the compressed position; (III) coupling the arrowhead to the coupling portion; (IV) returning the plunger to the extended position and thereby drawing the needle holder and the needle into an interior of the syringe casing; and (V) preventing reuse of the needle by either (a) altering the orientation of the needle axis with respect to the syringe casing axis from an orientation in which the axes were substantially parallel to an orientation in which the needle tip will encounter the circumferential wall if the plunger is moved back toward the compressed position or (b) disengaging the distal portion of the plunger by breaking the weak part.
In the method in which the preventing reuse of the needle is preformed by altering the orientation of the needle axis with respect to the syringe casing, a further step is possible. This method may also include bending the needle when the needle tip encounters the circumferential wall when the plunger is subsequently moved toward the compressed position.
In addition, in the method in which the preventing reuse of the needle is performed by disengaging the distal portion of the plunger from the weak part, the disengagement may occur if the weak part of the plunger is comprised of a plurality of tines which are easily broken upon application of a bending moment applied to the plunger when the plunger is in the extended position.